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Vivus files for OK of menopause treatment

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Published: Dec. 12, 2006 at 10:28 AM

MOUNTAIN VIEW, Calif., Dec. 12 (UPI) -- Vivus said Tuesday it filed with the U.S. Food and Drug Administration a new drug application for EvaMist, a potential treatment for menopause.

EvaMist consists of a transdermal spray that delivers estradiol via the skin for the treatment of hot flashes associated with menopause.

"We are pleased to announce the FDA acceptance of our submission for EvaMist," said Leland Wilson, Vivus' president and chief executive officer. "We are already working with the agency," Wilson added.

A phase 3 trial released earlier this year that involved 454 menopausal women found that those who were treated with EvaMist experienced a 78 percent reduction in the number of hot flashes.

© 2006 United Press International, Inc. All Rights Reserved. Any reproduction, republication, redistribution and/or modification of any UPI content is expressly prohibited without UPI's prior written consent.

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